Dong-A ST announced that its ECG monitoring platform, Hicardi+ H100, developed by digital healthcare startup Meju, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This clearance includes the cloud-based software LiveStudio, which enables medical professionals to perform biosignal analysis and generate reports.
Hicardi+ H100 is a patch-type device designed for long-term continuous ECG monitoring, measuring ECG, heart rate, and other relevant metrics. It is currently utilized in South Korea for cardiac disease screening in outpatient clinics, health check-up centers, and veterans hospitals.
The FDA approval follows previous certifications from Japan's PMDA and Saudi Arabia's SFDA. According to Dong-A ST, this approval marks the first instance in Korea of a smart patch utilizing on-device machine learning technology to analyze biosignals in real-time directly from the patch.
Executive Perspectives
Jeong Jae-hoon, CEO of Dong-A ST, stated that 2024 has been a pivotal year for establishing the Hicardi solution in the domestic market. He added, "We will accelerate our efforts to support overseas expansion with the FDA approval as a catalyst."
Park Jeong-hwan, CEO of Meju, noted that the FDA approval will serve as a stepping stone for the Hicardi solution to enter the world's largest digital healthcare market. "This certification was achieved through continuous consultation and support from various organizations," Park said.
Device Functionality
Hicardi+ H100 provides continuous ECG monitoring, which can aid in the detection of intermittent arrhythmias or other cardiac abnormalities that may not be evident during a standard ECG. The device's ability to perform real-time analysis via on-device machine learning could potentially reduce the time required for diagnosis and improve patient outcomes.
